BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980023 · Supplement: S019 · Decision Jul 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS, RV, SL, RV-S, SLS
    PMA Number
    P980023
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 2005
    Date Received
    December 19, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE KENTROX FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES KENTROX RV, KENTROX RV STEROID, KENTROX SL, KENTROX SL STEROID, KENTROX RV-S, KENTROX RV-S STEROID, AND KENTROX SLS STEROID AND ARE INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)